MAUDE Adverse Event Report: DATASCOPE FAIRFIELD SENSATION PLUS 8FR. 50CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0575

Device Problem Backflow (1064)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/27/2018

Event Type  malfunction  

Manufacturer Narrative

The product has been returned to the manufacturer, but is pending investigation.Once the investigation is completed a supplemental report with our findings will be submitted.(b)(4).

Event Description

It was reported that during intra-aortic balloon (iab) therapy there was blood backed up in the catheter and it stopped augmenting.A new iab was used to continue therapy.There was no reported injury to the patient.

Event Description

It was reported that during intra-aortic balloon (iab) therapy there was blood backed up in the catheter and it stopped augmenting.A new iab was used to continue therapy.There was no reported injury to the patient.

Manufacturer Narrative

Additional information: added lot #, serial #, and expiration date.Added initial reporter's email address.Added manufacture date.Device evaluation: the product was returned with the membrane completely unfolded and blood on the exterior of the catheter and within the stat-gard sleeve.No blood was observed inside the iab catheter.A clear fluid was observed inside the returned iab catheter.One kink was observed on the catheter tubing near the y-fitting approximately 76.2cm from the iab tip.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and no leaks were detected.We were unable to perform a pump test due to the iab catheter returned condition.An evaluation of the product was unable to duplicate the reported problem.The product performed according to specification.A device and lot history record review was completed for the reported product.No non-conformances were found that are considered to be related to the event.(b)(4).

• Brand Name: SENSATION PLUS 8FR. 50CC IAB
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE FAIRFIELD; 15 law drive; fairfield NJ 07004
• MDR Report Key: 7527067
• MDR Text Key: 108993858
• Report Number: 2248146-2018-00350
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• PMA/PMN Number: K112327
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/13/2021
• Device Catalogue Number: 0684-00-0575
• Device Lot Number: 3000069503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2018
• Device Age: YR
• Initial Date Manufacturer Received: 04/27/2018
• Initial Date FDA Received: 05/18/2018
• Supplement Dates Manufacturer Received: 06/01/2018
• Supplement Dates FDA Received: 06/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1